[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Assuta Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100589151","impact-of-protein-supplementation-and-resistance-training-on-body-composition-functional-parameters-metabolic-adaptation-and-nitrogen-balance-in-adults-aged-45-years-and-older-with-overweight-or-obesity-receiving-incretin-based-medications-100589151",false,"NCT06950684","Impact of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults Aged 45 Years and Older With Overweight or Obesity Receiving Incretin-based Medications","The Effect of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults (Aged ≥45 Years) With Overweight\u002FObesity Receiving Incretin-Based Weight Loss Medication for 6 Months: A Multicenter RCT","PRIME","Inclusion Criteria:\n\n* Adults aged ≥45 years.\n* Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity).\n* Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro).\n* Able to read and speak Hebrew fluently.\n\nExclusion Criteria:\n\n* Medical contraindications for incretin-based weight-loss medications.\n* Current treatment with insulin or sulfonylurea medications.\n* Inflammatory bowel disease.\n* Active or unstable psychiatric disorders or cognitive impairment.\n* Active bulimia nervosa.\n* Previous bariatric surgery or bariatric endoscopic procedures.\n* Use of other weight management medications within the past month.\n* Weight loss of ≥5% within the past three months.\n* Implanted cardiac pacemaker or other electronic implants.\n* Regular resistance training within the past three months.\n* Regular use of protein supplements.\n* Allergy or intolerance to dairy proteins or vegan lifestyle.","ALL","45 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight\u002Fobesity receiving weekly Incretin-Based obesity management medication treatment for 6 months.\n\nA parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein\u002Fday) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance.\n\nAll participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.",[27,28,29],"Obesity","Overweight (BMI &gt; 25)","Weight Loss",[31,32,33,34,35,36,37,38,39,40],"Protein supplementation","Resistance training","Body composition","Metabolic rate","Nitrogen balance","Incretin-based medications","Wegovy","Mounjaro","Older adults","Obesity treatment","NOT_YET_RECRUITING","2025-04-27",{"date":44,"type":45},"2025-04-30","ACTUAL",{"date":47,"type":21},"2025-07-01",{"date":49,"type":21},"2028-07-01",{"name":51,"class":52},"Assuta Medical Center","OTHER",""]